The new In Vitro Diagnostics Regulation (IVDR) transitional arrangements have now been published to the great relief of all stakeholders.
EUR-Lex - 52021PC0627 - EN - EUR-Lex (europa.eu)
The diagram below helps to explain what the new arrangement look like.
Whilst the extension to the transitional arrangements for some products is welcomed it shakes up everyone’s implementation plans and requires the focus be switched to those devices that do not benefit from the transitional arrangements. For example, Class A accessories such as wash buffers and instruments whilst the technical file may be less complex for a class A device it still takes time to prepare. These are a few considerations:
- Class A devices including accessories and instruments need to be CE marked under the IVDR by 26 May 2022.
- 2021/0323 (COD) states that the declaration of conformity must be signed before 26 May 2022; however, it would be advisable to also register, so allow some extra time for this because the system will be busy.
- If you have devices that are completing their design process in Q1 2022, will the technical file be complete by 26 May 2022 to enable CE marking under the IVDD to take advantage of the extended transition period or will you apply directly to a Notified body for the IVDR?
- IVDR reviews are taking 9-11 months once an application has been accepted by the Notified Body.
- All manufacturers should be upgrading their QMS to the IVDR because there is no transition for this, consider updating:
- IVDR implementation plan to realign planning with the revised regulation. Remember to update the design process to include performance evaluation process including the Performance Evaluation Plan and Report, Scientific Validity Report plus the Analytical and Clinical Performance Reports, GSPR checklist etc.
- clinical performance study processes to include ISO 20916
- the post market process including vigilance processes per Article 110(3). Note this takes effect from 26 May 2022)
- Economic Operator registration in EUDAMED per Article 27 (applicable for 26 May 2022)
There is a lot to consider, but as we said before it is really important, don’t take your foot off the gas! There is still a lot of work to do.